On June 5, 2022 Creatv Bio, Division of Creatv MicroTech, Inc., reported the release of an abstract featuring the results of its LifeTracDx blood test for predicting response of metastatic breast cancer (mBC) to new lines of therapy following a single cycle of therapy induction (Press release, Creatv Bio, JUN 5, 2022, View Source [SID1234615586]). The results will be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting June 3-7, 2022, one of the most influential oncology events in the world for presenting new cutting-edge advances in cancer science that will shape the future of cancer treatment.

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Creatv Bio’s poster presents data showing that analysis of circulating stromal cells and circulating tumor cells from the blood of mBC patients undergoing therapy can predict tumor responsiveness to a new line of therapy within a single cycle of treatment, regardless of disease subtype or drug classification, including the cancer vaccine, Bria-IMTTM, developed by BriaCell Therapeutics Corp. (NASDAQ: BCTX) (TSX: BCT).

Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date and Time: June 5th, 2022, 8:00AM-11:00AM
Poster Title: Tracking Changes in Circulating Stromal Cells and Circulating Tumor Cells Predicts Responsiveness of New Line Induction in Metastatic Breast Cancer after 1 Cycle of Therapy
Poster Location: Poster number: 48; Abstract number: 3056

Daniel L. Adams, Creatv Bio Director of Clinical R&D, stated, "We are excited for the opportunity to present these results to the leaders in oncology and hope this study leads to larger interventional trials that one day will help all cancer patients. LifeTracDx ‘s ability to rapidly identify MBC patients responding to a new therapeutic regimen after only one cycle of treatment could eventually be used to rapidly assess and alter patient’s therapy in real time, leading to improved patient outcomes."

"We are looking forward to continuing our work with the experts at Creatv Bio as we advance the clinical development of our novel cellular immunotherapy for advanced breast cancer," stated Dr. Giuseppe Del Priore, Chief Medical Officer of BriaCell. "We are hopeful that the technology will allow us to better identify breast cancer patients most likely to benefit from novel therapies."

On June 5, 2022 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, reported a collaboration with Arvinas, Inc., to develop FoundationOneLiquid CDx as a companion diagnostic for use with Arvinas’ bavdegalutamide (ARV-110), an investigational novel PROTAC protein degrader targeting the androgen receptor (AR) (Press release, Foundation Medicine, JUN 5, 2022, View Source [SID1234615583]). Arvinas’ bavdegalutamide is being developed for the potential treatment of men with metastatic castration resistant prostate cancer (mCRPC) who have progressed on existing therapies.

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Arvinas is a clinical-stage biotechnology company and a pioneer in the rapidly growing field of targeted protein degradation. Arvinas’ proprietary PROTAC targeted protein degraders, or proteolysis-targeting chimeras, work by harnessing the body’s natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. AR activity is a key driver of prostate cancer, which makes the ability to regulate AR signaling an important factor in controlling disease progression.

"We look forward to collaborating with Foundation Medicine to develop a companion diagnostic aimed at improving patient access," said Ron Peck, M.D., chief medical officer at Arvinas. "Foundation Medicine’s deep understanding of cancer genomics, scalable solutions, and regulatory expertise makes them an ideal partner for us as we develop bavdegalutamide as a potential new therapy for men with prostate cancer."

Foundation Medicine’s portfolio of FDA-approved comprehensive genomic profiling tests offer physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. As companion diagnostics, FoundationOneCDx and FoundationOneLiquid CDx allow oncologists to identify patients who may be appropriate for FDA-approved targeted therapies.

"We are proud to serve as an end-to-end partner for Arvinas as they pioneer this new approach to treat cancer," said Sanket Agrawal, chief biopharma business officer, Foundation Medicine. "Bringing our capabilities to this emerging area of biotechnology sets us on an exciting path to deepen our collective understanding of cancer biology and deliver more novel treatment options to patients now and in the future."

Foundation Medicine is an essential partner for biopharma organizations navigating the complexity of cancer care and research. This latest collaboration adds to its more than 65 global biopharma and biotechnology partnerships aimed at getting targeted cancer treatments to patients faster.

About FoundationOneCDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit www.F1CDxLabel.com.

About FoundationOneLiquid CDx

FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and genomic alteration status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.

On June 5, 2022 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, reported that results from a Phase 1 dose escalation monotherapy trial with CYT-0851 in a poster titled "Phase 1 Results of CYT-0851 in Patients with Advanced Solid and Hematologic Cancers" (Abstract: 3084, Poster: 76) at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, Illinois (Press release, Cyteir Therapeutics, JUN 5, 2022, View Source [SID1234615582]).

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"Data presented today from the Phase 1 dose escalation study with CYT-0851 show that the drug has performed well in advanced, relapsed and/or refractory cancer patients: it has desirable pharmacologic properties with an estimated half-life of three days, dose proportional exposure, and a dose dependent, predictable, and favorable safety profile. In addition, anti-tumor activity was observed with disease stabilization and responses in patients with solid tumors and hematologic malignancies, supporting the advancement of CYT-0851, as a potentially first-in-class drug, into Phase 2 expansion cohorts as a monotherapy and Phase 1 in combination with standard of care treatment regimens," said Markus Renschler, MD, President and Chief Executive Officer of Cyteir. "The Cyteir team continues to execute on the clinical development of CYT-0851 and we look forward to sharing data in the second half of 2022."

Phase 1 Dose Escalation Results

The primary objectives of the Phase 1 dose escalation trial with CYT-0851 were to determine the recommended Phase 2 dose, determine the maximum tolerated dose (MTD) and to evaluate safety and tolerability. Key secondary objectives include determination of the pharmacokinetic parameters, optimal dosing regimen and preliminary anti-tumor activity. As of the April 13, 2022 data cutoff, 80 patients were enrolled across twelve dose-escalation cohorts from 30 mg to 1200 mg total daily dose. Eighty patients were evaluable for safety and 65 patients were evaluable for efficacy.

The maximum tolerated dose was determined to be 600 mg once a day for both solid tumors and hematologic malignancies. The recommended Phase 2 dose is 400 mg once a day, a convenient and commercially attractive schedule.

Key Findings

In solid tumors:

Forty-five patients were response evaluable and one unconfirmed partial response (PR) was achieved in a patient with soft-tissue sarcoma who was treated for almost 11 months
Nineteen patients (42%) had stable disease and twelve patients (27%) had a decrease in target lesion size for an overall disease control rate of 44%
Stable disease (42%) was seen in patients with soft-tissue sarcoma, head and neck squamous cell, pancreatic, ovarian, and breast cancers
In hematologic cancers:

Eighteen patients with non-Hodgkin lymphoma were response evaluable
Responses were seen in patients with follicular lymphoma (1 complete response (CR) and 1 PR) and diffuse large B-cell lymphoma (1 PR)
Three patients with follicular lymphoma, one patient with diffuse large B-cell lymphoma and one patient with hairy-cell leukemia achieved stable disease
Patients responding to CYT-0851 exhibited a durable clinical benefit as evidenced by the more than 18 months of treatment in the patient with follicular lymphoma who achieved a CR
Safety:

To date, CYT-0851 has exhibited a generally well tolerated safety profile with 42% of patients reporting no treatment related adverse events (TRAEs)
At the recommended Phase 2 dose or below, no patient discontinued therapy for TRAEs
The most common TRAEs were fatigue (18%), alopecia (14%), nausea (11%), hyperuricemia (10%), constipation (8%) and anemia (8%)
The dose limiting toxicity was reversible metabolic acidosis, consistent with the mechanism of action of the drug
"The Phase 1 data for monotherapy CYT-0851 has demonstrated promising clinical activity with a manageable safety profile across a wide array of cancers in a heavily pretreated patient population," said Dr. Ryan C. Lynch, Assistant Professor at the Fred Hutchinson Cancer Center and first author of the study. "The broad activity coupled with the mechanistic understanding that CYT-0851 is impacting cancer cell metabolism creates a promising therapeutic approach for use in a wide range of cancers."

CYT-0851 Mechanism of Action Insights Have Potential to Expand into Additional Tumor Types

Based on new molecular, bioinformatic, and biochemical characterization research that has been done at Cyteir to elucidate the mechanism of action of CYT-0851, management believes that the observed effects of CYT-0851 on the viability of cancer cells are due to inhibition of monocarboxylate transporter (MCT) activity and the subsequent disruption of lactate transport. Monocarboxylate transporters are essential proteins in cancer metabolism making MCTs an attractive target for cancer therapy. This new understanding of the mechanism of action of CYT-0851 could potentially accelerate development of a biomarker and allow for expansion into additional opportunities in other tumor types.

Data from the Ongoing Phase 2 Monotherapy Expansion Cohorts and Phase 1 Combination Study Expected in 2H 2022

Cyteir continues to make progress advancing CYT-0851 in monotherapy and combination clinical studies. Enrollment is ongoing in six disease-specific Phase 2 expansion cohorts with monotherapy in hematologic malignancies and solid tumors. Completion of enrollment in stage 1 of this study is expected before the end of 2022. Enrollment is also ongoing in a Phase 1 combination study of CYT-0851 with three standard-of-care regimens: (1) rituximab plus bendamustine; (2) gemcitabine; and (3) capecitabine, in both hematologic malignancies and solid tumors. Initial safety data from this combination study is expected before the end of 2022.

On June 5, 2022 NANOBIOTIX (Euronext : NANO –– Nasdaq: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported the reporting of new data at the 2022 Annual Meeting of the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) featuring potential first-in-class radioenhancer NBTXR3 in combination with concurrent chemoradiation for the treatment of head and neck cancer and rectal cancer (Press release, Nanobiotix, JUN 5, 2022, View Source [SID1234615581]). Nanobiotix also presented a trial-in-progress poster on the study design of the Company’s ongoing pivotal phase 3 study, NANORAY-312, evaluating NBTXR3 as a single agent activated by radiotherapy for the treatment of elderly and frail patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who are ineligible for platinum-based chemotherapy (cisplatin).

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In view of the Company’s strategy for development of NBTXR3 as a product candidate that can integrate across solid tumor indications along with major treatment modalities within each indication, starting with head and neck cancer, the company believes these new data add support for the radioenhancer in combination with chemoradiation and as a neoadjuvant (preoperative) therapy with the potential to improve surgical outcomes. "Revolutionizing treatment outcomes for millions of patients with cancer will require integration of NBTXR3 across solid tumor indications, treatment modalities, and lines of therapy where radiation is a part of the treatment regimen—starting with head and neck cancer," said Laurent Levy, co-founder and chairman of the executive board at Nanobiotix. "Taken together with the clinical data we have already produced for NBTXR3 as a single agent activated by radiotherapy and as a combination agent with anti-PD-1, we view the new chemoradiation data presented at ASCO (Free ASCO Whitepaper) as critical validation of NBTXR3’s feasibility across the standard of care. As we continue to prioritize our ongoing pivotal phase 3 study for elderly and frail patients with locally advanced head and neck squamous cell carcinoma, our aim is to build a comprehensive approach to the treatment of patients with locally advanced head and neck cancer that will serve as a model for our radioenhancer in other indications."

A Comprehensive Approach to Locally Advanced Head and Neck Cancer Inclusive of Chemoradiation

Most cisplatin-eligible patients with LA-HNSCC receive multimodal therapy including high dose concurrent chemoradiation (CCRT) as the standard of care. While CCRT has shown to improve local control and extend survival, the toxicity of high dose cisplatin creates challenges. These challenges appear both in terms of compliance with the treatment regimen for patients undergoing therapy that can impair efficacy, and in terms of the patients’ quality of life after treatment. Although changes to the treatment protocol have been explored in randomized studies to reduce toxicity and improve compliance, reduction in toxicity has also led to reduction in efficacy.

These patients need innovative new therapeutic options that do not create additional burden in their administration, do not add combined toxicity to radiotherapy and chemotherapy, and have the potential to improve survival.

A Phase 1b/2 Study Evaluating NBTXR3 in Combination with Concurrent Chemoradiation for Patients with Locally Advanced or Recurrent Head and Neck Squamous Cell Carcinoma

This study, sponsored, executed, and reported by former Nanobiotix collaborator in Asia, PharmaEngine, Inc. (PEI), sought to evaluate the safety and feasibility of NBTXR3 intratumoral injection when added to low-dose weekly cisplatin-containing CCRT for patients with locally advanced or recurrent head and neck squamous cell carcinoma. The study also aimed to establish the recommended phase 2 dose (RP2D), however the RP2D was not determined due to stoppage of the phase 1b part of the trial resulting from the conclusion of the collaboration between PEI and Nanobiotix in 2021.

Adult patients with T3-4 LA-HNSCC suitable for cisplatin were eligible for the study and 12 such patients were enrolled. These patients received a single intratumoral injection of NBTXR3, followed by a low-dose weekly regimen of CCRT. All 12 patients were deemed evaluable and all had stage 4 locally advanced disease.

Of these evaluable patients, 3, 6, and 3 patients received NBTXR3 at the 5%, 10%, and 15% dose levels, respectively. No serious adverse events (SAEs) inconsistent with what would normally be expected from a low-dose CCRT regimen were observed. Dose-limiting toxicities of grade 3 increased ALT and grade 3 increased AST were observed in one patient at the 10% dose level. Common Grade 3 adverse events (AEs) observed across dose levels were stomatitis, decreased WBC, decreased appetite, decreased neutrophil count, and leukopenia. One patient experienced grade 4 hyponatremia.

Preliminary efficacy results showed a disease control rate of 100%, with an overall response rate of 58.3% according to RECIST 1.1. The study concluded that adding a single intratumoral injection of NBTXR3 to weekly low dose cisplatin-containing CCRT was feasible and had a favorable safety profile for patients with LA-HNSCC.

Strengthening Support for NBTXR3 in Combination with Chemoradiation in the Preoperative Setting

Colorectal cancer (CRC) is the third most common cancer indication worldwide and the second leading cause of cancer-related death in the United States. One-third of CRCs appear in the rectum. For patients with locally advanced rectal cancer (LARC), combined modality therapy with neoadjuvant CCRT, followed by total mesorectal excision (TME; surgery), followed by adjuvant (post-operative) systemic chemotherapy is the current standard of care. The aim of the neoadjuvant portion of the treatment regimen is to control and downstage the disease to allow for R0 TME (surgical removal with a negative margin in which no gross or microscopic tumor remains in the primary tumor bed), as clinical studies have shown a positive correlation between improved cancer-specific survival and R0 TME. While outcomes have improved, patients are still faced with a highly toxic treatment regimen that can lead to a lack of compliance which may hamper efficacy, along with deteriorated quality of life after treatment.

Innovation with the potential to improve the rate of R0 resection without adding toxicity is an urgent need for this patient population.

A Phase 1b/2 Study Evaluating NBTXR3 in Combination with Concurrent Chemoradiation in the Neoadjuvant Setting for Patients with Locally Advanced or Unresectable Rectal Cancer

This study, sponsored, executed, and presented by PEI, sought to evaluate safety, feasibility, and early signs of efficacy for neoadjuvant NBTXR3 combined with CCRT followed by surgery for patients with locally advanced or unresectable rectal cancer. The study established the recommended phase 2 dose of NBTXR3 at 22% of gross tumor volume, however the phase 2 part of the trial was stopped as a result of the conclusion of the collaboration between PEI and Nanobiotix in 2021. Adult and older patients with T3-T4 locally advanced or unresectable rectal cancer suitable for chemoradiation were eligible for the study and 32 such patients were enrolled. These patients received a single intratumoral injection of NBTXR3, followed by a weekly regimen of CCRT. 31 of 32 patients were deemed evaluable and none of the evaluable patients had tumors eligible for surgery at the time of diagnosis.

Of the 31 evaluable patients, 6, 4, 3, and 18 patients received NBTXR3 at the 5%, 10%, 15%, and 22% dose levels, respectively. No NBTXR3-related SAEs or grade ≥ 3 AEs were observed. The most frequently reported AEs were grade 1 or 2 decreased WBC, diarrhea, increased CRP, UTI, and decreased lymphocyte count which were all consistent with what would normally be expected from CCRT.

Preliminary efficacy results showed a disease control rate of 100%, with an overall response rate of 35.5% according to RECIST 1.1. Pathological tumor downstaging was observed in 14 of 31 patients after therapy, 25 patients underwent surgery, and 96% of those patients achieved R0 surgical margins. Pathological complete response was observed in 20% of the patients who received surgery. The study concluded that a single intratumoral injection of NBTXR3 in combination with CCRT is feasible and has a favorable safety profile in the neoadjuvant setting for patients with locally advanced or unresectable rectal adenocarcinoma.

***

About NBTXR3

NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

On June 5, 2022 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that updated efficacy and safety results from the teclistamab Phase 1/2 MajesTEC-1 study.1 Teclistamab is an investigational, off-the-shelf, T-cell redirecting bispecific antibody targeting B-cell maturation antigen (BCMA), which is being studied in patients with relapsed or refractory multiple myeloma (RRMM) (Press release, Johnson & Johnson, JUN 5, 2022, View Source [SID1234615579]).1 The data were featured as part of an oral session during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Applications seeking approval of teclistamab are currently under health authority review in the United States (U.S.) and Europe.

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The multicohort, open-label, Phase 1/2 MajesTEC-1 study is investigating the safety and efficacy of teclistamab in patients with RRMM who received at least three prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.3 As of March 2022, 165 patients were treated with teclistamab at the recommended subcutaneous (SC) Phase 2 dose (RP2D) of 1.5 mg/kg preceded by step-up doses of 0.06 mg/kg and 0.3 mg/kg across both Phase 1 (NCT03145181) and Phase 2 (NCT04557098) of the study.1

Longer Follow-up from MajesTEC-1 Study in Patients with Triple Class Exposed Multiple Myeloma (Abstract #8007)

At a median follow-up of 14.1 months (range, 0.26-24.4), an overall response rate (ORR) of 63 percent (95 percent Confidence Interval [CI], range, 55.2-70.4) was observed in patients with triple class exposed multiple myeloma, with a complete response (CR) or better achieved in 39.4 percent of patients.1 Study participants had three or more prior lines of therapy, with a median of five prior lines, including a prior proteasome inhibitor, immunomodulatory drug and anti-CD38 antibody​.1 The majority of patients were triple-class refractory and/or refractory to their last line of treatment.1 Although response duration data are not mature, the median duration of response at this time is 18.4 months and has not been reached in patients who achieved a CR or better (95 percent CI, 14.9 not estimable).1 This suggests responses to teclistamab were durable and deepened over time.1 The medium progression-free survival (PFS) was 11.3 months (95 percent CI, 8.8–17.1).1 Adverse events (AEs) were low-grade for the most part and manageable with no new safety signals seen.1

These results from the MajesTEC-1 study were also simultaneously published online in The New England Journal of Medicine.2

"The longer term results from the MajesTEC-1 study suggest that patients are able to achieve deep and durable responses when treated with teclistamab," said Maria-Victoria Mateos, M.D., Ph.D., Consultant Physician in Haematology, University Hospital of Salamanca.* "These encouraging data reinforce the potential of teclistamab as a monotherapy for eligible patients with heavily pretreated multiple myeloma, in need of new treatment options."

No new safety signals were observed with longer follow-up.1 In 14.1 month follow-up data presented, the most common grade 3/4 haematologic AEs were neutropenia (64.2 percent); anaemia (37 percent); lymphopenia (32.7 percent) and thrombocytopenia (21.2 percent).1 Infections occurred in 76.4 percent of patients (44.8 percent grade 3/4).1 The most common nonhaematologic AE was cytokine release syndrome (CRS), all of which were grade 1/2 except for one transient grade 3 CRS (72.1 percent all grade).1 The median time to CRS onset was two days (range, 1-6) and median duration was two days (range, 1-9).1 There were five treatment-related deaths, and dose reductions and discontinuations due to AEs were infrequent.1

First Results from Cohort C of the MajesTEC-1 Study of Teclistamab in Patients with RRMM with Prior Exposure to BCMA Targeted Treatment (Abstract #8013)

Initial results were also presented from Cohort C of the MajesTEC-1 study evaluating teclistamab in the treatment of patients with RRMM who had previously been exposed to an anti-BCMA treatment.4 These patients had received a median of six prior lines of therapy, most (85 percent) were triple-class refractory and 35 percent were penta-drug refractory.4 The use of teclistamab following prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy and/or an antibody drug conjugate (ADC) (e.g., belantamab mafodotin) targeting BCMA resulted in a promising response rate in patients with heavily pretreated RRMM.4 At a median follow-up of 12.5 months (range, 0.7-14.4), the ORR was 52.5 percent (95 percent CI, 36.1-68.5) among 40 patients who received teclistamab in Cohort C.4 Responses to teclistamab occurred early and deepened over time, with comparable response rates in patients previously treated with an ADC and/or CAR-T.4

A tolerable side-effect profile was observed in patients previously treated with anti-BCMA treatment, with no dose reductions or discontinuations due to AEs.4 The safety profile for Cohort C was comparable with that observed in BCMA treatment-naive patients, with no new safety signals.4 In 12.5 month follow-up data, 26 patients (65 percent; 30 percent grade 3/4) had infections.4 The most common AEs (n=40) were CRS (65 percent any grade), with a median time to CRS onset and duration of two days (range, 2-6) and two days (range, 1-4) respectively.4 Cytopenias (grade 3/4) were noted as follows; neutropenia (62.5 percent); thrombocytopenia (30 percent); anaemia (35 percent); and lymphopenia (42.5 percent).4

"Patients with relapsed or refractory multiple myeloma have limited treatment options and only 30 percent will be able to achieve a response using conventional therapies," said Edmond Chan MBChB M.D. (Res), EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. "While unmet needs remain, we continue to be dedicated to developing innovative treatment approaches that improve outcomes for people living with multiple myeloma, at all stages of the disease."

Initial Patient-Reported Health-Related Quality of Life (HRQoL) Outcomes in Patients with RRMM Treated with Teclistamab (Abstract #8033)

Initial results from an analysis of patient-reported health-related quality of life (HRQoL) outcomes following treatment with teclistamab were also shared in a poster session.5 The study analysed patient-reported assessments of quality of life metrics among patients in the MajesTEC-1 trial who had received their first treatment dose by March 18, 2021.5 The metrics analysed include function (physical, role, emotional, cognitive, social); symptoms (fatigue, nausea/vomiting, pain, appetite loss, constipation, diarrhoea); and generic health (mobility, self-care, usual activities, pain/discomfort, anxiety/depression).5 Over 80 percent of the 110 patients included in the patient-reported outcomes (PRO) analysis noted meaningful improvement (percentages of patients with clinically meaningful change from baseline (EORTC QLQ-C30 scales: ≥10 points)) in at least one of the symptom scales.5 Reduction in pain scores occurred as early as cycle two.5 At the moment, no meaningful improvement was observed in the scales for physical functioning and fatigue.5 These initial PRO results complement recent clinical data and support teclistamab as a potential off-the-shelf, T-cell redirecting therapy for patients with RRMM.5

As of September 7, 2021, median duration of treatment was 5.7 months and median follow-up was 7.8 months.5 Global health​ status scores significantly improved from baseline (95 percent CIs for least squares mean change did not cross 0) at cycles four, six, and eight; emotional functioning significantly improved at all time points.5 PRO assessments included European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 item (EORTC QLQ-C30).5 PROs were assessed on day one of each treatment cycle (28 days per cycle).5 Additional follow-up is needed to assess the full benefit of meaningful improvement in functional outcomes.5

"The updated data presented at ASCO (Free ASCO Whitepaper) support the ongoing evaluation of teclistamab for the treatment of relapsed or refractory multiple myeloma," said Yusri Elsayed, M.D., M.HSc., Ph.D., Vice President, Disease Area Leader, Hematologic Malignancies, Janssen Research & Development, LLC. "These results underscore our ongoing commitment to address the unmet need for new therapeutic options and our effort to bring forward novel treatments for multiple myeloma patients in the near future."

#ENDS#

About Teclistamab

Teclistamab is an investigational, fully humanised IgG4, T-cell redirecting, bispecific antibody targeting both BCMA and CD3, on T-cells.1 BCMA is expressed at high levels on multiple myeloma cells.6,7,8,9,10 Teclistamab redirects CD3-positive T-cells to BCMA-expressing myeloma cells to induce killing of tumor cells.11

Teclistamab is currently being evaluated in several monotherapy and combination studies.3,12,13,14,15 In 2020, the European Commission (EC) and the U.S. Food and Drug Administration (FDA) each granted teclistamab Orphan Drug Designation for the treatment of multiple myeloma. In January 2021 and June 2021, teclistamab received a PRIority MEdicines (PRIME) designation by the European Medicines Agency (EMA) and Breakthrough Therapy Designation (BTD) by the FDA, respectively. PRIME offers enhanced interaction and early dialogue to optimise drug development plans and speed up evaluation of cutting-edge, scientific advances that target a high unmet medical need.16 The U.S. FDA grants BTD to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition and is based on preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.17 In December 2021, Janssen submitted a Biologics License Application (BLA) to the FDA seeking approval of teclistamab for the treatment of patients with RRMM; a marketing authorisation application (MAA) was submitted to the EMA for teclistamab approval in January 2022.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.18 In multiple myeloma, cancerous plasma cells change and grow out of control.18 In Europe, more than 50,900 people were diagnosed with multiple myeloma in 2020, and more than 32,500 patients died.19 While some patients with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms, which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels or kidney failure.20